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Woman and man looking out over a river with SPIRIVA RESPIMAT 2.5 mcg Inhalation Spray soft mist

Real-world evidence in COPD: SPIRIVA RESPIMAT 2.5 mcg vs 
LAMA DPI

Real-world evidence vs LAMA DPI shows that inhaler choice matters1

This retrospective, real-world analysis by inhaler type was based on a claims database that included patients who had COPD and were using a LAMA (SMI or DPI).1,2

Fewer severe exacerbations and/or pneumonia diagnoses among patients initiating SPIRIVA RESPIMAT vs a LAMA DPI1,2*†

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12% fewer severe exacerbations and/or pneumonia diagnoses vs. a LAMA DPI

Fewer hospital readmissions

  • Readmissions: all-cause hospitalizations within 30 days of a COPD-related acute inpatient hospital discharge2†‡

34% fewer hospital readmissions vs. a LAMA DPI
  • *
    A single exacerbation or pneumonia diagnosis episode can include multiple healthcare touchpoints as long as they were within 14 days of each other.1
  • †
    Unadjusted total COPD-related costs were significantly lower for SPIRIVA RESPIMAT; after adjustments, the difference did not reach statistical significance. Unadjusted COPD-related HRU (outpatient and emergency department visits and inpatient stays) was significantly lower for SPIRIVA RESPIMAT; after adjustments, only outpatient visits were significantly lower. Unadjusted total all-cause costs were lower for SPIRIVA RESPIMAT; after adjustments, the differences were similar. Unadjusted all-cause HRU (outpatient and emergency department visits and inpatient stays) was significantly lower for SPIRIVA RESPIMAT; after adjustments, the results were no longer significant. The unadjusted time to initiation of triple therapy was similar in both groups; after adjustments, among patients who did not initiate triple therapy on the index date, the time to triple therapy initiation was significantly longer for SPIRIVA RESPIMAT.1
  • ‡
    N values indicate the number of hospitalizations per treatment group. A total of 9062 patients were included in the readmissions analysis: SPIRIVA RESPIMAT (n=1381) and LAMA DPI (n=7681).1

LAMA, long-acting antimuscarinic agent; DPI, dry powder inhaler; SMI, soft mist inhaler; HRU, healthcare resource utilization.

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Study Design

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The objectives of this retrospective analysis were to describe real-world patients initiating a LAMA by inhaler device type (SMI or DPI) and to compare follow-up healthcare costs and utilization.1

  • Objectives were to evaluate by inhaler type differences in all-cause and COPD-related costs, all-cause and COPD-related healthcare resource utilization (HRU), severe and moderate acute COPD-related exacerbations, and time to initiation of triple therapy
  • Claims data from the Optum Research Database of Medicare Advantage beneficiaries were used
  • Cohorts were balanced on baseline characteristics
  • COPD-related exacerbations consisted of ≥1 COPD-related healthcare utilization event, including COPD exacerbations and/or pneumonia diagnoses. They are classified as:
    • Severe: a hospitalization or emergency department visit with a COPD or pneumonia diagnosis
    • Moderate: an ambulatory visit with a COPD or pneumonia diagnosis and a pharmacy claim for an oral corticosteroid or a guideline-recommended respiratory antibiotic within ±7 days

LAMA, long-acting antimuscarinic agent; DPI, dry powder inhaler; SMI, soft mist inhaler.

  • COPD severity based on lung function and other clinical characteristics such as smoking status, symptomatology, and peak inspiratory flow rate are unavailable in claims data
  • Patients were required to have continuous enrollment with medical and pharmacy coverage for a minimum of 30 days following the index date. However, this did not guarantee that patients were treated with the index medication for at least 30 days

Results from real-world studies are not intended for comparisons with clinical trials. Real-world studies were observational trials. Differences in study designs, patient populations, outcomes definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

SPIRIVA is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium, or any component of either product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

 

IMPORTANT SAFETY INFORMATION (cont’d)

SPIRIVA is intended as a once-daily maintenance treatment for COPD and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA. If such a reaction occurs, discontinue SPIRIVA at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA.

SPIRIVA HANDIHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

Inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist, such as albuterol. Treatment with SPIRIVA should be stopped and other treatments considered.

SPIRIVA should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Since dizziness and blurred vision may occur with the use of SPIRIVA, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.

SPIRIVA should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in COPD trials were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

The most common adverse reactions >5% incidence and exceeded placebo by ≥1% with SPIRIVA HANDIHALER (placebo) in COPD trials were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4-year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

SPIRIVA may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HANDIHALER device, and the HANDIHALER device should not be used for administering other medications.

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

Please see full Prescribing Information for SPIRIVA RESPIMAT, including Instructions for Use, and full Prescribing Information for SPIRIVA HANDIHALER, including Patient Information and Instructions for Use.

CL-SVR-0036 2.8.2016

REFERENCES

  1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

  2. Singer D, Bengtson LGS, Elliott C, Buikema AR, Franchino-Elder J. Healthcare resource utilization, exacerbations, and readmissions among Medicare patients with chronic obstructive pulmonary disease after long-acting muscarinic antagonist therapy initiation with soft mist versus dry powder inhalers. Int J Chron Obstruct Pulmon Dis. 2020;15:3239-3250.